Speaker Profile

Sarah Witwer

Regulatory Compliance Advisor,
Pearl Pathways

Sarah Witwer is a Regulatory Advisor for Pearl Pathways and has over 30 years of experience in drug and device development with particular skills in CMC (Chemistry Manufacturing and Controls). She is a seasoned regulatory professional with proven expertise in developing regulatory strategies, writing successful submission packages, negotiating submissions with global health authorities, and managing CMC manufacturing issues. Sarah also has extensive stability protocol development experience as well as real world know-how in managing manufacturing plant changes for small and large molecules. In addition to her career at a large pharmaceutical company (Lilly,) prior to working at Pearl Pathways, Sarah worked for a contract manufacturer and appreciates the demands of a service provider. Sarah is RAC certified, and is a microbiologist and lawyer with degrees from Miami University and Indiana University.